A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma
Lead SponsorAltair Therapeutics
StatusCompleted No Results Posted
Intervention/Treatmentair645 sodium chloride ...
This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.
AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)
Physiologic saline solution
Inclusion Criteria*: Good General Health (with or without allergic rhinitis and/or controlled asthma) Non-smoker for at least 2 years Normal lung function (DLCO) Able to provide informed consent and to understand and comply with the requirements of the study Exclusion Criteria*: Clinically significant medical history or condition which precludes participation Clinically significant ECG abnormality Clinically significant VS or PE abnormality Clinically significant screening lab abnormality Abnormal lung function (FEV1 <80% predicted) Respiratory infection within 14 days of randomization HBV, HCV, or HIV Breastfeeding or pregnant female History of alcohol abuse or illicit drug use within past 24 months Use of any tobacco or nicotine-containing product within past 6 months Use of any herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol Use of any investigational drug within past 30 days Use of any investigational monoclonal antibody or recombinant protein within past 90 days Donation of plasma within past 7 days Donation or loss of whole blood within past 56 days Simplified list of I/E criteria; unabridged list available upon request.